ZONISAMIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZONISAMIDE (UNII: 459384H98V) (ZONISAMIDE - UNII:459384H98V)

Available from:

Proficient Rx LP

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Zonisamide Capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. Zonisamide Capsules are contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide.

Product summary:

Zonisamide Capsules USP, for oral administration, are available as 100 mg Hard gelatin capsules of size "1" with light red opaque cap and white to off white opaque body imprinted "Ú" on cap and "430" on body with black ink, containing white to off white granular powder and supplied as: NDC 71205-727-30 bottles of 30 NDC 71205-727-60 bottles of 60 NDC 71205-727-90 bottles of 90 Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature], in a dry place and protected from light. Additional Medication Guide can be obtained by calling Unichem at 1-866-562-4616 Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India. Manufactured for: East Brunswick, NJ 08816 Repackaged by: PROFICIENT RX LP Thousand Oaks, CA 91320 02-R-07/2020

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Proficient Rx LP
----------
SPL MEDGUIDE
MEDICATION GUIDE
Zonisamide (zoe nis' a mide) Capsules
What is the most important information I should know about Zonisamide
Capsules?
Zonisamide Capsules may cause serious side effects, including:
1.
Serious skin rash that can cause death.
2.
Serious allergic reactions that may affect different parts of the
body.
3.
Less sweating and increase in your body temperature (fever).
4.
Serious eye problems
5.
Suicidal thoughts or actions in some people.
6.
Increased level of acid in your blood (metabolic acidosis).
7.
Problems with your concentration, attention, memory, thinking, speech,
or language.
8.
Blood cell changes such as reduced red and white blood cell counts.
These serious side effects are described below.
1. Zonisamide Capsules may cause a serious skin rash that can cause
death. These serious skin reactions
are more likely to happen when you begin taking zonisamide within the
first 4 months of treatment but may
occur at later times.
2. Zonisamide Capsules can cause other types of allergic reactions or
serious problems that may affect
different parts of the body such as your liver, kidneys, heart, or
blood cells. You may or may not have a rash
with these types of reactions. These reactions can be very serious and
can cause death. Call your health care
provider right away if you have:
•
fever
•
severe muscle pain
•
rash
•
swollen lymph glands
•
swelling of your face
•
unusual bruising or bleeding
•
weakness, fatigue
•
yellowing of your skin or the white part of your eyes
3. Zonisamide Capsules may cause you to sweat less and to increase
your body temperature (fever). You
may need to be hospitalized for this. You should watch for decreased
sweating and fever, especially when it
is hot and especially in children taking Zonisamide Capsules.
Call your health care provider right away if you have:
•
high fever, recurring fever, or long lasting fever
•
less sweat than normal
4. Zonisamide Capsules may cause eye problems. Serious eye problems
include:
•
s

Summary of Product characteristics

ZONISAMIDE- ZONISAMIDE CAPSULE
PROFICIENT RX LP
----------
ZONISAMIDE CAPSULES USP, FOR ORAL ADMINISTRATION
RX ONLY
DESCRIPTION
Zonisamide Capsules USP, are an antiseizure drug chemically classified
as a sulfonamide
and unrelated to other antiseizure agents. The active ingredient is
zonisamide, 1,2 -
benzisoxazole-3-methanesulfonamide. The empirical formula is C H N O S
with a
molecular weight of 212.23. Zonisamide is a white to off white powder,
pKa = 10.6, and
is freely soluble in dimethyl formamide, soluble in methanol.
The chemical structure is:
Zonisamide Capsules USP, are supplied for oral administration as
capsules containing
100 mg zonisamide.
Each capsule contains the labeled amount of zonisamide plus the
following inactive
ingredients: hydrogenated vegetable oil, microcrystalline cellulose,
colloidal silicon
dioxide, sodium lauryl sulfate, gelatin and titanium dioxide.
Additionally the 50 mg
contains D&C Red No. 28 and FD&C Blue No. 1 and the 100 mg contains
FD&C Red No.
40.
The black imprinting ink contains shellac, propylene glycol, black
iron oxide and
potassium hydroxide.
CLINICAL PHARMACOLOGY
MECHANISM OF ACTION: The precise mechanism(s) by which zonisamide
exerts its
antiseizure effect is unknown. Zonisamide demonstrated anticonvulsant
activity in
several experimental models. In animals, zonisamide was effective
against tonic
extension seizures induced by maximal electroshock but ineffective
against clonic
seizures induced by subcutaneous pentylenetetrazol. Zonisamide raised
the threshold
for generalized seizures in the kindled rat model and reduced the
duration of cortical
focal seizures induced by electrical stimulation of the visual cortex
in cats. Furthermore,
zonisamide suppressed both interictal spikes and the secondarily
generalized seizures
produced by cortical application of tungstic acid gel in rats or by
cortical freezing in cats.
The relevance of these models to human epilepsy is unknown.
Zonisamide may produce these effects through action at sodium and
calcium channels.
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